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B-Cell MalignanciesPhase 2NCT04509700

Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

A Phase 2 study testing Parsaclisib, parsaclisib + itacitinib and parsaclisib + ruxolitinib in people with B-Cell Malignancies, run by Incyte Corporation at 105 sites in 17 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a Phase 2, multicenter, open-label study to provide continued supply of parsaclisib as monotherapy or in combination therapy with itacitinib, ruxolitinib, or ibrutinib to participants from Incyte-sponsored studies of parsaclisib. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-Cell Malignancies
What is being tested?
Parsaclisib, parsaclisib + itacitinib and parsaclisib + ruxolitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
105 sitesin 17 countries
Study dates
3 Aug 2020to 5 Nov 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Currently enrolled and receiving treatment in an Incyte-sponsored clinical study of parsaclisib.
  • Currently tolerating treatment in the parent Protocol.
  • Currently receiving clinical benefit from treatment with parsaclisib as monotherapy or in combination therapy with Itacitinib, ruxolitinib, or ibrutinib as determined by the investigator.
  • Has at least stable disease, as determined by the investigator.
  • Has demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements.
  • Willingness and ability to comply with scheduled visits, treatment plans, including PJP prophylaxis, and any other study procedures indicated in this Protocol.
  • Willingness to avoid pregnancy or fathering children
  • Ability to comprehend and willingness to sign an ICF

Who cannot join

  • Has been permanently discontinued from study treatment in the parent Protocol for any reason.
  • Able to access parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib therapy outside a clinical study.
  • Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol.
  • Pregnant or breastfeeding women.

Trial locations and contacts

105 sites in 17 countries.

105 sites in 17 countries

United States26 sites

  • University of Michigan Cancer Center

    Ann Arbor, Michigan, 48109

  • Rocky Mountain Cancer Center

    Aurora, Colorado, 80012

  • Rcca Md, Llc

    Bethesda, Maryland, 20817

  • Uab Comprehensive Cancer Center

    Birmingham, Alabama, 35233

  • University of Alabama At Birmingham

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Rush University Medical Center-Consultants in Hematology

    Chicago, Illinois, 60612

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Ohio State University

    Columbus, Ohio, 43210

  • Baylor Scott White Univeristy Medical Center

    Dallas, Texas, 75246

  • City of Hope National Medical Center

    Duarte, California, 31010

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • California Cancer Associates For Research and Excellence

    Fresno, California, 93720

  • Hattiesburg Clinic Hematology

    Hattiesburg, Mississippi, 39401

  • Saint Luke'S Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Hca Midwest Health-Research Medical Center

    Kansas City, Missouri, 66211

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Innovative Clinical Research Institute

    Long Beach, California, 90805

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Mayo Clinic Rochester

    Phoenix, Arizona, 85054

  • Knight Cancer Institute At Oregon Health and Science University

    Portland, Oregon, 97239

  • University of Washington-Seattle Cancer Care Alliance

    Seattle, Washington, 98109-4405

  • University of Arizona Cancer Center-Out Pt.

    Tucson, Arizona, 85719

  • University of Kansas Hospital Authority

    Westwood, Kansas, 66205

Other trials in United States

Japan19 sites

  • Juntendo University Hospital

    Bunkyō City, 113-8431

  • National Cancer Center Hospital

    Chūō, 104-0045

  • Kansai Medical University Hospital

    Hirakata, 573-1191

  • Tokai University Hospital

    Isehara, 259-1193

  • Irb of Kobe City Medical Center General Hospital

    Kobe, 650-0047

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Nho Matsumoto Medical Center

    Matsumoto-shi, 399-8701

  • Miyagi Cancer Center

    Miyagi, 981-1293

  • Jrc Aichi Medical Center Nagoya Daini Hospital

    Nagoya, 466-8650

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Osaka Metropolitan University Hospital

    Osaka, 545-8585

  • Hokuyukai Sapporo Hokuyu Hospital

    Sapporo, 003-0006

  • National Hospital Org. Hokkaido Cancer Center

    Sapporo, 003-0804

  • Tohoku University Hospital

    Sendai, 980-8574

  • Tokyo Medical University Hospital

    Shinjuku, 160-0023

  • Tenri Hospital

    Tenri, 632-8552

  • Nippon Medical School Hospital

    Tokyo, 113-8603

  • Yokohama Municipal Citizens Hospital

    Yokohama, 221-0855

  • University of Fukui Hospital

    Yoshida-gun, 910-1193

Other trials in Japan

Italy14 sites

  • University of Bologna Institute of Haematology L E A Seragnoli

    Bologna, 40126

  • Lstituto Di Ematologia Lorenzo Ea.Seragnoli Universita Degli Studi Di Bologna - Policlinico S. Or

    Bologna, 40138

  • Azienda Ospedaliero-Universitaria Careggi (Aouc)

    Florence, 50134

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori

    Meldola (FC), 47014

  • Fondazione Irccs Ca Granda Ospedale Maggiore

    Milan, 20122

  • Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano

    Milan, 20133

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano

    Milan, 22162

  • Universita Di Napoli Federico Ii

    Naples, 80131

  • Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara

    Novara, 28100

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

    Palermo, 90146

  • Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara

    Pisa, 56126

  • Ospedale Santa Maria Delle Croci

    Ravenna, 48121

  • Ospedale Sant. Eugenio

    Roma, 00144

Other trials in Italy

Spain14 sites

  • Hospital General Unviersitario de Alicante

    Alicante, 03010

  • Germans Trias I Pujol

    Badalona, 08916

  • Hospital Del Mar

    Barcelona, 08003

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Hospital Clinic I Provincial

    Barcelona, 08036

  • Start Madrid - Ciocc

    Boadilla del Monte, 28660

  • Institut Catala Doncologia - Hospital Duran I Reynals

    L'Hospitalet de Llobregat, 08908

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28009

  • Hospital Universitario Fundacin Jimnez Daz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Hm Sanchinarro

    Madrid, 28050

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, 28233

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

Other trials in Spain

France6 sites

  • Chru de Brest Hospital Morvan

    Brest, 29200

  • Centre Antoine Laccassagne

    Nice, 06189

  • Ap-Hp Groupe Hospitalier Saint-Louis Lariboisiere Fernand-Widal Site Saint Louis (Paris)

    Paris, 75010

  • Hospital Universitaire Pitie-Salpetriere

    Paris, 75013

  • Centre Hospitalier Universitaire de Toulouse

    Toulouse, 31059

  • Chru Hopitaux de Tours Hospital Bretonneau

    Tours, 37000

Other trials in France

Belgium4 sites

  • Cliniques Universitaires Ucl Saint-Luc

    Brussels, 01200

  • Universitair Ziekenhuis Gent (Uz Gent)

    Ghent, 09000

  • Az Groeninge

    Kortrijk, 08500

  • Universitaire Ziekenhuis Leuven - Gasthuisberg

    Leuven, 03000

Other trials in Belgium

Czechia4 sites

  • University Hospital Hradec Kralove

    Hradec Králové, 50005

  • Univerzita Karlova V Praze 1. Lekarska Fakulta

    Prague, 128 00

  • Fakultni Nemocnice V Motole

    Prague, 15000

  • University Hospital Kralovkse Vinohrady

    Prague

Other trials in Czechia

Poland4 sites

  • Sp Zoz Szpital Uniwersytecki

    Kracow, 31-501

  • Wwcoit Im. M. Kopernika W Lodzi

    Lodz, 93-513

  • Szpital Specjalistyczny Im. Jedrzeja Sniadeckiego W Nowym Saczu

    Nowy Sącz, 33-300

  • Samodzielny Publiczny Szpital Kliniczny Nr 1

    Wroclaw, 20-081

Other trials in Poland

Denmark3 sites

  • Aarhus University Hospital

    Århus N, 08200

  • Rigshospitalet

    Copenhagen, 02100

  • Sjaellands Universitetshospital

    Roskilde, 04000

Other trials in Denmark

Israel3 sites

  • Hadassah Hebrew University Medical Center Ein Karem Hadassah

    Jerusalem, 91120

  • Rabin Medical Center - Beilinson Hospital

    Petah Tikva, 49100

  • Sheba Medical Center

    Tel HaShomer, 5265601

Other trials in Israel

Turkey (Türkiye)2 sites

  • Istanbul Medipol Universitesi Ibagcilar Medipol Mega Universitesi Hastanesi

    Istanbul, 34214

  • Ege University Hospital

    Izmir, 35040

Other trials in Turkey (Türkiye)

Austria1 site

  • Medical University of Vienna

    Vienna, 01090

Other trials in Austria

Hungary1 site

  • Petz Aladar County Teaching Hospital

    Győr, 09024

Other trials in Hungary

Norway1 site

  • Haukeland University Hospital

    Bergen, 05021

Other trials in Norway

South Korea1 site

  • The Catholic University of Korea Seoul St. Mary'S Hospital

    Seoul, 06591

Other trials in South Korea

Sweden1 site

  • Karolinska University Hospital Solna

    Stockholm, 171 76

Other trials in Sweden

United Kingdom1 site

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

Other trials in United Kingdom

About this study

Official title: A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

This is a Phase 2, multicenter, open-label study to provide continued supply of parsaclisib as monotherapy or in combination therapy with itacitinib, ruxolitinib, or ibrutinib to participants from Incyte-sponsored studies of parsaclisib.

Read the detailed description

The purpose of this study is to provide continued use of parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib to participants who are currently enrolled in an Incyte-sponsored study and receiving the same treatment, who have at least stable disease, who are obtaining clinical benefit (in the opinion of the investigator) on the current study treatment, as defined by the parent Protocol, and who are unable to access parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib outside a clinical study. Participants will continue on the same dose and schedule as the ones being administered in the Incyte-sponsored parent Protocol at the time of the rollover. The study will collect and assess safety information with regards to AEs.

Being tested
Parsaclisib, parsaclisib + itacitinib, parsaclisib + ruxolitinib, parsaclisib + ibrutinib
Keywords
non-Hodgkin lymphoma, phosphatidylinositol 3-kinase, myeloproliferative neoplasm
Medical subject headings
Lymphoma, Non-Hodgkin, Myeloproliferative Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ParsaclisibDrug

    Also called INCB050465

    Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib as that provided in the parent Protocol at the time of the rollover.

  • parsaclisib + itacitinibDrug

    Also called INCB050465, INCB39110

    Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 100 mg of itacitinib as that provided in the parent Protocol at the time of the rollover.

  • parsaclisib + ruxolitinibDrug

    Also called INCB050465, INCB018424

    Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and the same dose of ruxolitinib that was provided in the parent Protocol at the time of the rollover.

  • parsaclisib + ibrutinibDrug

    Also called INCB050465

    Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 140 mg of ibrutinib as that provided in the parent Protocol at the time of the rollover.

Study groups in NCT04509700
Study groupRoleWhat they receive
parsaclisibExperimentalParticipants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib as that provided in the parent Protocol at the time of the rollover.
Receives: Drug: Parsaclisib
parsaclicib + itacitinibExperimentalParticipants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 100 mg of itacitinib as that provided in the parent Protocol at the time of the rollover.
Receives: Drug: parsaclisib + itacitinib
parsaclisib + ruxolitinibExperimentalParticipants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and the same dose of ruxolitinib that was provided in the parent Protocol at the time of the rollover.
Receives: Drug: parsaclisib + ruxolitinib
parsaclisib + ibrutinibExperimentalParticipants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 140 mg of ibrutinib as that provided in the parent Protocol at the time of the rollover.
Receives: Drug: parsaclisib + ibrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Number of participants with treatment-related AEs

    Measured: Through study completion, an average of 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2020
  2. Study start3 Aug 2020
  3. Primary completion5 Nov 2026 (estimated)
  4. Study completion5 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04509700
Sponsor's protocol ID
INCB 50465-801
Other IDs
2022-501687-18-00, 2019-004948-30, 2019
Status last verified
Jun 2026
First submitted
10 Aug 2020
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Parsaclisib, parsaclisib + itacitinib and parsaclisib + ruxolitinib in people with B-Cell Malignancies, run by Incyte Corporation at 105 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in United States, Japan, Italy, Spain, France and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Through study completion, an average of 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04509700.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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